# K070902: Modification to: Ensite System, Model, EE3000

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: May 1, 2007 after 29 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001437 (2000). 5 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060954: Modification to Ensite System, Model EE3000, St. Jude Medical, Inc.-Endocardial Solutions (2006) Summary page 1.

## Most influential descendants
- K130750: Rhythmia Mapping System (2013), 4 descendants of its own
- K162793: RHYTHMIA HDx Mapping System (2017), 3 descendants of its own
- K173837: RHYTHMIA HDx Mapping System (with software Version 2.0) (2018), 2 descendants of its own
- K192438: Rhythmia HDxTM Mapping System (2019), 1 descendant of its own
- K241227: RHYTHMIA HDx™ Mapping System (2024), 0 descendants of its own

## Indications for use
The EnSite System is indicated for patients for whom electrophysiology studies are indicated. When used with the EnSiteTM Catheter, the EnSite System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR When used with the EnSite NavXe Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology catheters in the heart.

Source page: https://510kreport.com/device/K070902
Methodology: https://510kreport.com/methodology